Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)

Phase 3

Completed

• Conditions: Herpes Zoster
• Interventions: Biological: ZOSTAVAX™; Biological: Placebo to ZOSTAVAX™; Biological: Influenza Vaccine

• Registration Number: NCT02519855
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-11
• Study Start: 2015-09-11
• Primary Completion: 2016-01-26
• Study Completion: 2016-01-26
• Results First Submitted: 2016-12-22
• Results First Submitted QC: 2016-12-22
• Results First Posted: 2017-02-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 882

Inclusion Criteria

• Has history of varicella or residence in a VZV-endemic area for ≥30 years
• Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study

Exclusion Criteria

• Has history of hypersensitivity to any vaccine component
• Has previously received any varicella or zoster vaccine
• Has received an influenza vaccine for the 2015-16 season
• Has history of Herpes zoster
• Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
• Is pregnant or breastfeeding, or expecting to conceive during the study
• Has used immunosuppressant therapy
• Has known or suspected immune dysfunction
• Has experienced Guillain-Barré syndrome within 6 weeks
• Has severe thrombocytopenia or any other coagulation disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concomitant Vaccination	Placebo to ZOSTAVAX™	ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
Concomitant Vaccination	Influenza Vaccine	ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
Nonconcomitant Vaccination	Placebo to ZOSTAVAX™	Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
Concomitant Vaccination	ZOSTAVAX™	ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
Nonconcomitant Vaccination	ZOSTAVAX™	Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
Nonconcomitant Vaccination	Influenza Vaccine	Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody	Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)	Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers	Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)	Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
Geometric Mean Titers of H1N1-specific Influenza Virus Antibody	Baseline and 4 weeks after Influenza vaccination (Week 4)	Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Geometric Mean Titers of H3N2-specific Influenza Virus Antibody	Baseline and 4 weeks after Influenza vaccination (Week 4)	Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody	Baseline and 4 weeks after Influenza vaccination (Week 4)	Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody	Baseline and 4 weeks after Influenza vaccination (Week 4)	Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.